Even as the volume of mergers and acquisitions in 2019 reached the highest level in the last 10 years, multiple big pharma companies are looking to get smaller, spinning off units into separate entities. Read More
Pediatric gene editing specialist Logicbio Therapeutics Inc. has revealed an FDA clinical hold on a planned phase I/II trial of its lead candidate, LB-001, an investigational therapy for rare inherited metabolic disorder methylmalonic acidemia (MMA). Read More
LONDON – As the death toll passed 1,000 and the number of confirmed cases reached 42,000, the World Health Organization on Feb. 11 convened 400 scientists at a global research and innovation forum to draw up an R&D blueprint for “pathogen X,” now officially named COVID-19. Read More
The three founders of newly launched Volastra Therapeutics Inc. had plenty in common when they decided to create the company. Their offices happened to be a half block apart on 69th Street in midtown Manhattan. Their interests in oncology were similar but each approached the disease from different angles. Read More
Multiple tactics employed by the biopharma industry to improve the recruitment and retention of participants in clinical trials seem to be paying off. More than three of four (77%) studies now fully enroll on or ahead of schedule, according to researchers at the Tufts Center for the Study of Drug Development (CSDD), reporting in the January/February Tufts CSDD Impact Report on global recruitment performance benchmarks. Read More
The Association for Accessible Medicines (AAM) is garnering support in its Ninth Circuit challenge to a new California law that seemingly thumbs its nose at a 2013 U.S. Supreme Court ruling on so-called pay-for-delay patent settlements. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Astellas, Avrobio, Biophytis, Cassava, City of Hope, Crescita, Cyclo, Da Volterra, Dermata, Elicio, Exelixis, Lidds, Moderna, NGM, Pfizer, Seattle Genetics, Sellas, Soligenix, T3D. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Brainstorm, Eli Lilly Canada, Fennec, Incyte, Ionis, Janssen, Logicbio, Lyndra, Marker, Novartis, Phasebio, Sirnaomics. Read More
